Lilla Strobel on ISO13485Tech Regulatory | Quality ConsultantSome time ago
So how you decide if your product is a medical device? Does it anything to do with doctors? With patients? With drugs? With other medical devices? With patient data? Well, if one of these is the case there is a good chance you have a medical device, what is the next step? Quality Assurance! If you want to develop, manufacture, distribute medical devices, you should follow ISO13485:2016! Are you ready kids?
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